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Comparison of Continuous ESP Versus TEA After Thoracotomy

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05008614
Collaborator
Seoul National University (Other)
62
Enrollment
1
Location
2
Arms
23.8
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective, randomized, assessor-blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided continuous erector spinae plane (ESP) block in patients undergoing thoracotomy. We hypothesize that US-guided ESP block is not inferior to thoracic epidural analgesia in terms of postoperative pain control in these patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Erector spinae plane block group
  • Procedure: Thoracic epidural analgesia group
 N/A

Detailed Description

Adult patients undergoing elective unilateral thoracotomy for lung cancer resection are randomly allocated to receive US-guided ESP block (n=31) or thoracic epidural analgesia (n=31). Both procedures are performed prior to surgery. Each patient was assessed by a blinded investigator on postoperative day (POD) 1,2 and 3. The primary outcome is pain severity evaluated by a numeric rating scale (NRS) at POD1.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A prospective randomized controlled assessor-blinded non-inferiority trialA prospective randomized controlled assessor-blinded non-inferiority trial
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcome assessor not involved in this study will investigate the outcomes.
Primary Purpose:
Treatment
Official Title:
Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia After Thoracotomy: A Randomized Controlled Assessor-blinded Non-inferiority Trial
Actual Study Start Date :
Jul 22, 2021
Anticipated Primary Completion Date :
May 16, 2023
Anticipated Study Completion Date :
Jul 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Erector spinae plane block group (ESP group)

Patients receiving continuous unilateral ESP block. Interventions: Procedure: Ultrasound-guided unilateral ESP block via catheter placement for continuous infusion Drug: Ropivacaine 0.75% Injectable Solution Device: 21-gauge 85 mm perineural catheter, 18-gauge 100 mm stimulator needle (Silverstim, Vygon, Ecouen, France)

Procedure: Erector spinae plane block group
Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under ultrasound guidance in the procedure room. Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 18G 85 mm perineural catheter (Silverstim, Vygon, Ecouen, France) (basal infusion: 10ml/hr, bolus 5ml, lockout time: 20min)
Other Names:
  • ESP group

    		•
    Active Comparator: Thoracic epidural analgesia group (TEA group)

    Patients receiving thoracic epidural analgesia. Interventions: Procedure: Fluoroscopy-guided thoracic epidural analgesia Drug: Ropivacaine 0.75% Injectable Solution Device: 17-gauge Tuohy needle (FlexTip Plus®, Teleflex Medical, USA)

    Procedure: Thoracic epidural analgesia group
    Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under fluoroscopy guidance in the procedure room. Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 17-gauge catheter (FlexTip Plus®, Teleflex Medical, USA) (Silverstim, Vygon, Ecouen, France) (basal infusion: 3ml/hr, bolus 1ml, lockout time: 20min)
    Other Names:
  • TEA group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum postoperative pain score at rest on postoperative day 1 [Maximum pain score among the 9 am and 4 pm measurements on postoperative day 1]

      pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain)

    Secondary Outcome Measures

    1. Postoperative pain score at rest [9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3]

      Change in the pain score at rest measured by the 11-pointed numeric rating scale (0: none/10: worst pain) from postoperative day 1 to postoperative day 3

    2. Postoperative pain score at movement [9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3]

      Change in the pain score at movement measured by the 11-pointed numeric rating scale (0: none/10: worst pain) from postoperative day 1 to postoperative day 3

    3. Change in the total consumption (ml) of patient-controlled analgesia [9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3]

      total consumption (ml) of epidural or erector spinae plane patient-controlled analgesia

    4. Change in the quality of recovery-15 scale from baseline to postoperative day 3 [Day before surgery and 4pm on postoperative day 3]

      measured by the Korean version of the quality of recovery-15

    5. Postoperative pulmonary function test [3 months after surgery]

      measured at outpatient clinic

    6. Incidence of chronic postoperative pain [3 months after surgery]

      measure by the Korean version of the pain DETECT

    7. Incidence of chronic postoperative pain [6 months after surgery]

      measure by the Korean version of the pain DETECT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients scheduled to undergo elective thoracotomy for lung cancer

    • European Cooperative Oncology Group 0 or 1

    • American Society of Anesthesiologists (ASA) physical classification I-III

    • Willingness and ability to sign an informed consent document

    Exclusion Criteria:

    • patients with chronic postoperative pain after thoracic surgery

    • patients undergoing thoracotomy with chest wall resection

    • allergies to anesthetic or analgesic medications

    • patients with coagulopathy or who continue to take anticoagulants

    • preoperative liver or renal dysfunction

    • patients with chronic pain, chronic opioid, analgesic or antidepressant or anticonvulsant use

    • Do not understand our study

    • Medical or psychological disease that can affect the treatment response

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of KS013

    Sponsors and Collaborators

    • Seoul National University Hospital
    • Seoul National University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Susie Yoon, Assistant clinical professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05008614
    Other Study ID Numbers:
    • 2104-142-1214
    First Posted:
    Aug 17, 2021
    Last Update Posted:
    Aug 17, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Susie Yoon, Assistant clinical professor, Seoul National University Hospital
    thoracotomy
    lung cancer
    interfascial plane block
    nerve block
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Aug 17, 2021